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| ID | Type | Description | Link |
|---|---|---|---|
| W0265-03 | Other Identifier | Stiefel |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to demonstrate the safety and effectiveness of CT Gel in subjects with acne vulgaris. The hypothesis is that CT Gel is superior to Clindamycin Gel, Tretinoin Gel and Vehicle Gel for the treatment of acne vulgaris.
CT Gel is a fixed-combination product that addresses the multifactorial factors of acne vulgaris pathogenesis. Based on numerous nonclinical pharmacology studies of each active ingredient, it is expected that this new product will have three biological actions: 1) comedolytic, 2) antimicrobial, and 3) anti-inflammatory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | CT Gel |
|
| 2 | Active Comparator | Clindamycin Gel (clindamycin) |
|
| 3 | Active Comparator | Tretinoin Gel (tretinoin) |
|
| 4 | Placebo Comparator | Vehicle Gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT Gel | Drug | Topical gel consisting of clindamycin 1% and tretinoin 0.025%, applied once daily in the evening for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts. | Baseline, Week 12 |
| The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. Change is calculated as the Week 12 value minus the Baseline value. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 | Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research | Birmingham | Alabama | 35209 | United States | ||
| Coastal Clinical Research, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CT Gel | Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks |
| FG001 | Clindamycin Gel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Clindamycin Gel (clindamycin ) | Drug | Clindamycin 1% gel applied topically once daily in the evening for 12 weeks |
|
| Tretinoin Gel (tretinoin) | Drug | Tretinoin 0.025% gel applied topically once daily in the evening for 12 weeks |
|
| Vehicle Gel | Drug | Topical gel without clindamycin or tretinoin applied topically once daily in the evening for 12 weeks |
|
| Baseline, Week 12 |
| The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12 | The SGA score is a global evaluation of acne severity performed by participants at all visits and measured on a 5-point ordinal scale, where 0=My face is basically free of acne and 5=My face has blackheads and/or whiteheads. A score of 1=My face has several blackheads and/or whiteheads and small pimples, but there are no tender deep-seated bumps or cysts. | Week 12 |
| The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12 | The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. A score of 1=Skin Almost Clear: rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyper-pigmented, though not pink-red) requiring no futher treatment in the Investigator's opinion. | Week 12 |
| Mobile |
| Alabama |
| 33608 |
| United States |
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States |
| Center for Dermatology, Cosmetic and Laser Surgery | Fremont | California | 94538 | United States |
| University Clinical Trials | San Diego | California | 92103 | United States |
| Longmont Medical Research Network | Longmont | Colorado | 80501 | United States |
| FXM Research Corporation | Miami | Florida | 33175 | United States |
| FXM Research - Miramar | Miramar | Florida | 33027 | United States |
| Advanced Dermatolgy & Cosemtic Surgery | Ormond Beach | Florida | 32174 | United States |
| Dermatology Specialists | Louisville | Kentucky | 40202 | United States |
| Massachusettes General Hospital - Clinical Unit for Research Trials in Skin | Boston | Massachusetts | 02114 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Medical Center | Detroit | Michigan | 48202 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Skin Specialists, P.C. | Omaha | Nebraska | 68144 | United States |
| Academic Dermatology Research | Albuquerque | New Mexico | 87106 | United States |
| Dermatology Research Associates, Inc. | Cincinnati | Ohio | 45230 | United States |
| Yardley Dermatology Associates | Yardley | Pennsylvania | 19067 | United States |
| Clinical Partners, LLC | Johnston | Rhode Island | 02919 | United States |
| Dermatology Associates of Knoxville, P.C. | Knoxville | Tennessee | 37934 | United States |
| Tennessee Clinical Research | Nashville | Tennessee | 37215 | United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
| J & S Studies, Inc. | College Station | Texas | 77840 | United States |
| The Hair and Skin Research Treatment Center | Dallas | Texas | 75246 | United States |
| Dermatology Research Center, Inc. | Salt Lake City | Utah | 84124 | United States |
| Premier Clincial Research | Spokane | Washington | 99204 | United States |
| Advanced Healthcare | Milwaukee | Wisconsin | 53209 | United States |
| Dermatology And Skin Centre | Belize City | Belize |
| Dr. Moguel's Clinic | Belize City | Belize |
| K. Papp Clinical Research, Inc. | Waterloo | Ontario | N2J 1C4 | Canada |
| Windsor Clinical Research Center, Inc. | Windsor | Ontario | N8W 5L7 | Canada |
| Innovaderm Research, Inc. | Montreal | Quebec | H2K 4L5 | Canada |
Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks
| FG002 | Tretinoin Gel | Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks |
| FG003 | Vehicle Gel | Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | CT Gel | Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks |
| BG001 | Clindamycin Gel | Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks |
| BG002 | Tretinoin Gel | Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks |
| BG003 | Vehicle Gel | Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Absolute Change From Baseline in Lesion Counts (Total, Inflammatory, and Non-inflammatory) at Week 12 (End of Study) | Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts. | Intent-to-Treat (ITT) Population: all participants who were randomized to and received at least one application of study product. | Posted | Mean | Standard Deviation | lesions | Baseline, Week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | The Percentage of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. Change is calculated as the Week 12 value minus the Baseline value. | ITT Population | Posted | Number | percentage of participants | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12 | Acne lesion counts (inflammatory [papules, pustules, nodules], non-inflammatory [open and closed comedones], and total) were performed on the face of participants. Change from baseline is defined as Week 12 values minus Baseline values. The total lesion count is the sum of the inflammatory and non-inflammatory lesion counts. | ITT Population | Posted | Mean | Standard Deviation | percent change | Baseline, Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Participants With a Subjects Global Assessment Score of 0 or 1 at Week 12 | The SGA score is a global evaluation of acne severity performed by participants at all visits and measured on a 5-point ordinal scale, where 0=My face is basically free of acne and 5=My face has blackheads and/or whiteheads. A score of 1=My face has several blackheads and/or whiteheads and small pimples, but there are no tender deep-seated bumps or cysts. | ITT Population | Posted | Number | participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage of Participants Who Had ISGA Scores of 0 or 1 at Week 12 | The ISGA is a static ("snap-shot") evaluation of acne severity performed by an investigator/assessor at every visit. The ISGA score is measured on a 6-point ordinal scale, where 0=Clear and 5=Very Severe. A score of 1=Skin Almost Clear: rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyper-pigmented, though not pink-red) requiring no futher treatment in the Investigator's opinion. | ITT Population | Posted | Number | percentage of participants | Week 12 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CT Gel | Clindamycin 1% as clindamycin phosphate and tretinoin 0.025% (CT) applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks | 1 | 476 | 27 | 476 | ||
| EG001 | Clindamycin Gel | Clindamycin phosphate 1% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks | 1 | 467 | 34 | 467 | ||
| EG002 | Tretinoin Gel | Tretinoin 0.025% applied topically to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks | 3 | 464 | 27 | 464 | ||
| EG003 | Vehicle Gel | Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks | 1 | 242 | 18 | 242 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D002981 | Clindamycin |
| D014212 | Tretinoin |
| ID | Term |
|---|---|
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014801 | Vitamin A |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
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| Male |
|
| Asian |
|
| Black |
|
| Multiracial |
|
| Native Hawaiian/Other Pacific Islander |
|
| White |
|
| Missing |
|
| Non-Inflammatory Lesion Counts |
|
| Total Lesion Counts |
|
Inflammatory lesion count |
| 95 |
| Superiority or Other |
| Ranked ANCOVA | <0.001 | Inflammatory lesion count | 95 | Superiority or Other |
| Ranked ANCOVA | 0.004 | Non-inflammatory lesion count | 95 | Superiority or Other |
| Ranked ANCOVA | 0.550 | Non-inflammatory lesion count | 95 | Superiority or Other |
| Ranked ANCOVA | <0.001 | Non-inflammatory lesion count | 95 | Superiority or Other |
| Ranked ANCOVA | <0.001 | Total lesion count | 95 | Superiority or Other |
| Ranked ANCOVA | 0.016 | Total lesion count | 95 | Superiority or Other |
| Ranked ANCOVA | <0.001 | Total lesion count | 95 | Superiority or Other |
Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks |
|
|
|
| Vehicle Gel |
Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks |
|
|
|
Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks |
|
|
|
| OG003 |
| Vehicle Gel |
Topical application to the face (including forehead, nose, cheeks, and chin) once daily in the evening for 12 weeks |
|
|
|